| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
77-070 |
SOTALOL HYDROCHLORIDE TABLETS USP (AF),
80 MG, 120 MG, AND 160 MG |
GENPHARM INC. |
11/4/2005 |
| 2 |
77-310 |
CILOSTAZOL TABLETS, 50 MG |
SANDOZ INC. |
11/8/2005 |
| 3 |
65-256 |
AMOXICILLIN TABLETS USP, 500 MG AND 875
MG |
AUROBINDO PHARMA LIMITED |
11/9/2005 |
| 4 |
65-271 |
AMOXICILLIN CAPSULES USP, 250 MG AND 500
MG |
AUROBINDO PHARMA LIMITED |
11/9/2005 |
| 5 |
77-293 |
FUROSEMIDE TABLETS USP, 20 MG, 40 MG, AND
80 MG |
EXCELLIUM PHARMACEUTICAL, INC. |
11/9/2005 |
| 6 |
77-311 |
HYDROMORPHONE HYDROCHLORIDE TABLETS USP,
2 MG, 4 MG, AND 8 MG |
KV PHARMACEUTICAL COMPANY |
11/9/2005 |
| 7 |
77-394 |
SODIUM BICARBONATE INJECTION USP, 7.5%
(0.9 mEq/ML) AND 8.4% (1 mEq/ML) SYRINGES |
HOSPIRA, INC. |
11/9/2005 |
| 8 |
65-277 |
DOXYCYCLINE HYCLATE TABLETS USP, 20 MG
(BASE) |
LANNETT HOLDINGS, INC. |
11/10/2005 |
| 9 |
65-150 |
AZITHROMYCIN TABLETS, 600 MG |
TEVA PHARMACEUTICALS USA |
11/14/2005 |
| 10 |
65-153 |
AZITHROMYCIN TABLETS, 250 MG |
TEVA PHARMACEUTICALS USA |
11/14/2005 |
| 11 |
65-193 |
AZITHROMYCIN TABLETS, 500 MG |
TEVA PHARMACEUTICALS USA |
11/14/2005 |
| 12 |
65-209 |
AZITHROMYCIN TABLETS, 600 MG |
SANDOZ, INC. |
11/14/2005 |
| 13 |
65-211 |
AZITHROMYCIN TABLETS, 250 MG |
SANDOZ, INC. |
11/14/2005 |
| 14 |
65-212 |
AZITHROMYCIN TABLETS, 500 MG |
SANDOZ, INC. |
11/14/2005 |
| 15 |
65-218 |
AZITHROMYCIN TABLETS, 600 MG |
PLIVA HRVATSKA D.O.O. |
11/14/2005 |
| 16 |
65-223 |
AZITHROMYCIN TABLETS, 500 MG |
PLIVA HRVATSKA D.O.O. |
11/14/2005 |
| 17 |
65-225 |
AZITHROMYCIN TABLETS, 250 MG |
PLIVA HRVATSKA D.O.O. |
11/14/2005 |
| 18 |
65-235 |
CEFPROZIL TABLETS USP, 250 MG AND 500 MG
|
SANDOZ INC. |
11/14/2005 |
| 19 |
77-601 |
CITALOPRAM HYDROBROMIDE ORAL SOLUTION, 10
MG (BASE)/5 ML |
APOTEX INC. |
11/15/2005 |
| 20 |
65-253 |
CEPHALEXIN CAPSULES USP, 250 MG AND 500
MG |
AUROBINDO PHARMA LIMITED |
11/16/2005 |
| 21 |
40-596 |
PROMETHAZINE HYDROCHLORIDE TABLETS USP,
12.5 MG, 25 MG, AND 50 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
11/18/2005 |
| 22 |
76-527 |
OFLOXACIN OTIC SOLUTION, 0.3% |
APOTEX INC. |
11/18/2005 |
| 23 |
75-959 |
OCTREOTIDE ACETATE INJECTION, 0.2 MG(BASE)/ML
AND 1 MG (BASE)/ML; 5 ML VIALS |
SICOR PHARMACEUTICALS, INC. |
11/21/2005 |
| 24 |
77-127 |
NIFEDIPINE EXTENDED-RELEASE TABLETS USP,
30 MG AND 60 MG |
OSMOTICA PHARMACEUTICAL CORPORATION |
11/21/2005 |
| 25 |
65-188 |
AMPICILLIN AND SULBACTAM FOR INJECTION
USP, 10 G(BASE)/5 G(BASE) PER VIAL; 15 G |
G.C. HANFORD MANUFACTURING COMPANY |
11/25/2005 |
| 26 |
65-229 |
CEPHALEXIN CAPSULES USP, 250 MG AND 500
MG |
LUPIN LIMITED |
11/25/2005 |
| 27 |
76-496 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, 500 MG |
BARR LABORATORIES, INC. |
11/25/2005 |
| 28 |
77-624 |
GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG
|
MYLAN PHARMACEUTICALS, INC. |
11/28/2005 |
| 29 |
65-222 |
AMPICILLIN AND SULBACTAM FOR INJECTION
USP, 1 G(BASE)/500 MG(BASE) PER VIAL, AND 2 G(BASE)/1
G(BASE) PER VIAL |
INSTITUTO BIOCHIMICO ITALIANO, S.P.A. |
11/29/2005 |
| 30 |
76-434 |
CHLORHEXIDINE GLUCONATE ORAL RINSE USP,
0.12% |
JOHN O. BUTLER COMPANY |
11/29/2005 |
| 31 |
65-176 |
AMPICILLIN AND SULBACTAM FOR INJECTION
USP, 1 G(BASE)/500 MG(BASE) PER VIAL & PIGGYBACK BOTTLE; 2
G(BASE)/1 G(BASE) PER VIAL & PIGGYBACK BOTTLE |
G.C. HANFORD MANUFACTURING COMPANY |
11/30/2005 |
| 32 |
65-192 |
MUPIROCIN OINTMENT USP, 2% |
ALTANA INC. |
11/30/2005 |
| 33 |
76-835 |
FLAVOXATE HYDROCHLORIDE TABLETS, 100 MG |
HAMPTON LAINE, LLC |
11/30/2005 |
